Course Information for 4801 - bioDesign II
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Primary Instructor: Kelly W. Broadhead
Credits: 3.0
Semesters Offered:Fall
Frequency Offered:Annual
Prerequisites:BIOE 3801: Biomedical Engineering Design I
Class Schedule: 1 hour of lecture and 6 hours of lab per week
Catalog Description: Continuation of BIOEN 3801. Initial designs will be prototyped before going through a design review. Design verification issues and improvements will then be solved in a redesign phase following a design process based on FDA-QSR. Projects will be team oriented and lead to increased project management skills. In addition, discussions on design considerations will continue. A final written design document and an oral presentation of the working prototype will culminate the class. Lecture: 1 hour and Lab: 3 hours + 3 hours arranged.
Required Texts:FDA 21CFR820: Title 21--Food and Drugs, Subchapter H - Medical Devices, Part 820 Quality System Regulation (available on the web at
Optional Texts:Design Controls for the Medical Device Industry, Marie B. Teixeira and Richard Bradley, Marcel Decker, Inc. 2002. ISBN:0-8247-0830-X or (alternative) Design of Biomedical Devices and Systems, 1st Edition, P.H. King and R.C. Fries, Marcel Decker, Inc., 2003. ISBN:0-8247-0889-X
Course Website: www.bioen.utah/design
Course Syllabus:Syllabus_4801.pdf